Espoo, Finland (ots/PRNewswire) -
- Parkinson's Patients who Require the Start of Levodopa Therapy
may be Eligible to Participate in This Study
Orion Pharma and Novartis announced that they are launching
STRIDE-PD (STalevo Reduction In Dyskinesia Evaluation). This major
study in Parkinson's disease (PD) seeks to investigate if, when used
as initial therapy, the optimised levodopa medication Stalevo -
containing levodopa, carbidopa and entacapone - delays the onset of
motor complications, such as dyskinesias, compared to traditional
formulation of levodopa/carbidopa.
STRIDE-PD will enroll approximately 740 patients at 70 centres in
14 countries: Austria, Belgium, Canada, France, Finland, Germany,
Greece, Italy, Spain, Sweden, Turkey, Switzerland, the United Kingdom
and the United States of America. Patient recruitment has started in
September and is estimated to continue for 12 months. The first study
results are expected in 2007.
Patients with PD between 30 and 70 years of age who have been
diagnosed within the last five years prior to study initiation and
who require the start of levodopa therapy to manage their symptoms
may be eligible to participate in this two-year study.
"The importance of the STRIDE-PD study could be major. If the
study shows that Stalevo is superior to traditional
levodopa/carbidopa therapy in the time to onset of dyskinesias, this
could change the current treatment paradigm completely," said Werner
Poewe, Chair of the Department of Neurology at Innsbruck University,
Austria. "We would then use Stalevo from the very first day in
patients needing levodopa treatment."
Levodopa is the most effective and most widely used symptomatic PD
treatment and has remained the "gold standard" of care for nearly 40
years. The vast majority of people with PD eventually require
levodopa treatment to control their symptoms, even if they begin
their therapy with another drug. However, after several years of
treatment with levodopa, patients often begin to experience motor
complications, such as "wearing-off" (when the effect of one dose of
medication doesn't last until the next scheduled dose) and
dyskinesias.
Characterised by abnormal and involuntary movements, dyskinesias
are a major challenge for people with PD since they can result in
fragmented or jerky motions that are different from the rhythmic
tremor commonly associated with PD.
"We are very excited about the launch of STRIDE-PD. Dyskinesias
often become a serious problem for people with PD. Delaying the onset
of these motor complications would therefore offer a real improvement
in the quality of life for patients and their families," said Mary
Baker, President of the European Parkinson's Disease Association
(EPDA), United Kingdom.
For further information on STRIDE-PD, please also refer to
www.epda.eu.com.
About Stalevo
Stalevo (levodopa, carbidopa and entacapone) is a new and
optimised levodopa product with a longer duration of action compared
to traditional levodopa/carbidopa preparations.
Stalevo tablets are currently indicated for certain PD patients
who are experiencing "wearing-off" motor complications. In patients
with "wearing-off," clinical trials have shown that the addition of
entacapone to levodopa/carbidopa can significantly extend the
duration of benefit of each medication dose and enhance the PD
patients' ability to control body movements and perform basic
functions, such as walking and dressing.
The most common side effects of Stalevo therapy are dopaminergic
in nature (e.g. dyskinesia, nausea.) These side effects may be
manageable with alteration in the drug dosing schedule. Other common
side effects include diarrhea, hyperkinesias, urine discoloration,
hypokinesia, abdominal pain, dizziness, constipation, fatigue, pain
and hallucinations.
Stalevo, developed by Orion Pharma, is marketed by Novartis and
Orion Pharma in their respective territories. Stalevo is available in
Austria, Belgium, Brazil, Denmark, Iceland, Ireland, Finland, France,
Germany, Greece, Luxemburg, the Netherlands, Norway, Spain, Sweden,
Switzerland, the United Kingdom and the United States.
About Parkinson's disease
PD is a chronic and progressive neurological condition that
affects 6.3 million people worldwide. One per cent of people over the
age of 60 and two per cent of people over the age of 80 suffer from
this disease.
While their cause is unknown, PD symptoms are primarily the result
of a degeneration of dopaminergic cells, or neurons, in the
substantia nigra, a part of the brain that controls and modulates
movement.
Symptoms include limbs that tremble, slowness of movement,
stiffness and rigidity of limbs and gait or balance problems. As the
disease progresses, these symptoms usually increase and impact a
person's ability to work and function.
About Orion Pharma
Orion Pharma, the originator of entacapone and Stalevo, is a
research and development-orientated pharmaceutical division of the
Orion Group (HEX:ORNAS, ORNBS) and one of the leading companies in
the healthcare sector in the Nordic area of Europe. Pharmaceutical
R&D at Orion Pharma focuses on three core therapy areas: CNS
therapies, cardiology and critical care, and hormonal therapies.
Entacapone, a COMT enzyme inhibitor used in the treatment of
Parkinson's disease, is one of Orion Pharma's patented molecule
discoveries. It is available globally as Comtess and Comtan, and as
one of the three active compounds in the novel levodopa treatment,
Stalevo. For further information please consult http://www.orion.fi.
References
(I) Myllylä V, Haapaniemi T, Hartikainen P, Nuutinen J, Rissanen
A, Kuopio A-M, Jolma T, Satomaa O, Kinnunen E, Kaakkola S. First
experiences of new triple combination of levodopa/carbidopa/
entacapone in the treatment of patienst with Parkinson's disease
(2003) Eur J Neurol 10:suppl1 (163(P2140).
Brooks D, Agid Y, Østergaard K, Widner H and Oertel W, on behalf
of the TCINIT study group. A new triple combination tablet is easy to
initiate and provides improved symptom control in patients with
Parkinson's disease (2003) Eur J Neurol 10:Suppl1;241(P3108).
Parkinson's Disease Fact Sheet, European Parkinson's Disease
Association.
ots Originaltext: Orion Corporation
Im Internet recherchierbar: http://www.newsaktuell.ch
Contact:
Orion Pharma: Juha Ellmén, Orion Pharma R&D Clinical Development, tel
+358-10-429-7667 (direct), Mobile phone +358-50-429-7667,
juha.ellmen@orionpharma.com